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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K946074
Device Name ALDERSON BREST DOSIMETRY SYSTEM
Applicant
Radiology Support Devices, Inc.
1904 E. Dominguez St.
Long Beach,  CA  90810
Applicant Contact SAMUEL W ALDERSON
Correspondent
Radiology Support Devices, Inc.
1904 E. Dominguez St.
Long Beach,  CA  90810
Correspondent Contact SAMUEL W ALDERSON
Regulation Number892.5050
Classification Product Code
IYE  
Date Received11/29/1994
Decision Date 12/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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